(294 days)
The FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.
The subject devices are ASTM F2100 Level 1 (lavender in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) includes a malleable nosepiece. The FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) includes a visor and nose foam. These masks are single use, disposable devices, provided non-sterile.
The provided document is a 510(k) summary for a medical device (face masks) and describes non-clinical performance testing against established standards, not a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested information regarding AI acceptance criteria, training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the non-clinical testing summary as requested:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM F2101 (Bacterial Filtration Efficiency) | To demonstrate adequate bacterial filtration efficiency | Under the conditions of the study, at least 95% efficiency | Pass (≥ 95%) |
| EN 14683:2019+AC Annex C (Breathability) | To demonstrate acceptable breathability | Under the conditions of the study, at most 5.0 mm H2O/cm² | Pass (< 5.0 mmH2O/cm²) |
| ASTM F2299 (Particulate Filtration Efficiency) | To demonstrate adequate particulate filtration efficiency | Under the conditions of the study, at least 95% efficiency | Pass (≥ 95%) |
| ASTM F1862 (Fluid Resistance) | To demonstrate adequate resistance to liquids | Under the conditions of the study, passing at 80 mmHg conditions | Pass (80 mmHg) |
| 16 CFR 1610 (Flame Resistance) | To evaluate flame spread resistance | Class 1 under the conditions of the testing | Pass (Class 1) |
| ASTM F2100-19 (Mask Performance Level) | To evaluate mask performance | Level 1 under the conditions of the evaluation | Pass (Level 1) |
| EN ISO 11737-1 Bioburden (Microbial Cleanliness) | To evaluate microbial cleanliness | Under the conditions of the study, at most 30 CFU/g | Pass (< 30 CFU/g) |
| ISO 10993-5 (Cytotoxicity) | To evaluate the cytotoxic potential of the mask | Under the conditions of the study, non-cytotoxic | Pass (non-cytotoxic) |
| ISO 10993-10 Sensitization | To evaluate the sensitization potential of the mask | Under the conditions of the study, not a sensitizer | Pass (not a sensitizer) |
| ISO 10993-10 Irritation | To evaluate the irritation potential of the mask | Under the conditions of the study, not an irritant | Pass (not an irritant) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each test. The tests are non-clinical (e.g., material testing, not patient data). The provenance is not explicitly stated beyond being conducted for a US FDA 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. These are non-clinical performance tests against established standards (ASTM, ISO, EN), not diagnostic studies requiring expert human review to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or subjective interpretations that would require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device; it is a physical medical device (face mask).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests is defined by the specific performance and safety standards (e.g., ASTM F2101 for bacterial filtration efficiency, ISO 10993 for biocompatibility). The device's performance is compared directly against the quantitative or qualitative criteria set by these standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 1, 2024
Owens & Minor (O&M) Halyard, Inc. Caitlin Senter Director. Global Regulatory Affairs 9120 Lockwood Blvd Mechanicsville, Virginia 23116
Re: K232777
Trade/Device Name: FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 16, 2024 Received: May 17, 2024
Dear Caitlin Senter:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
anıl
For Bifeng Qian, M.D., Ph.D. Assistant Director
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DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232777
Device Name
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868), FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
Indications for Use (Describe)
The FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intention control practices to reduce the potential exposure of the wearer to blood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use, disposable device(s), provided non-sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Presentation Use (21 CFR 201.66) - Direct to Consumer | Sample Compounding (21 CFR 201.66) - Compounding |
|---|---|
| -------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color, with horizontal lines running through the letters. To the right of the letters is the company name "Owens & Minor" in gray. The ampersand symbol is placed between the two words.
510(k) Summary – K232777
| Date of Summary | July 1, 2024 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc. |
| 1 Edison Drive | |
| Alpharetta, GA 30005 | |
| Primary Contact for this | Caitlin Senter, MS, RAC |
| 510(k) Submission | Tel: 678-221-7330 |
| Email: caitlin.senter@owens-minor.com | |
| Marketed Common Name | Procedure Mask |
| Device Submission TradeName and Description | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops,Lavender (25868); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT*Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) |
| Device Product Code,Class andClassification Name | FXXIISurgical Apparel (21 CFR 878.4040) |
| Predicate Device | K110455Kimberly-Clark KC100 Face MasksFXX Surgical MaskSurgical Apparel (21 CFR 878.4040) |
| Subject Device Description | The subject devices are ASTM F2100 Level 1 (lavender in color) ProcedureMasks. The ASTM F2100 Level 1 Procedure Mask family of products are athree-layer mask, constructed of well-known non-woven materials used infacial protection. The FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Liningand SO SOFT* Earloops, Lavender (25868) includes a malleable nosepiece. TheFLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*Earloops, Lavender, Wrap Around Visor (41798) includes a visor and nosefoam.These masks are single use, disposable devices, provided non-sterile. |
| Indications for Use | The FLUIDSHIELD* 1 Procedure Mask(s) are intended to be worn to protect boththe patient and healthcare personnel from transfer of microorganisms, bodyfluids, and particulate material. These face masks are intended for use ininfection control practices to reduce the potential exposure of the wearer toblood and body fluids. FLUIDSHIELD* 1 Procedure Mask(s) are single use,disposable device(s), provided non-sterile. |
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Image /page/5/Picture/0 description: The image shows the logo for Owens & Minor. The logo consists of the letters "OM" in a dark red color on the left side of the image. To the right of the letters is the name of the company, "Owens & Minor", in a light gray color.
| Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| Subject Device | Subject Device | Predicate Device | Comparison | |
| FLUIDSHIELD* 1Procedure Mask with SOSOFT* Lining and SOSOFT* Earloops, Lavender(25868) | FLUIDSHIELD* 1 Fog-FreeProcedure Mask withSOO SOFT* Lining and SOSOFT* Earloops,Lavender, Wrap AroundVisor (41798) | KC100 Face Masks(K110455) | ||
| FDA ProductCode | FXX | FXX | FXX | Same |
| FDAClassification | Class II | Class II | Class II | Same |
| RegulationNumber | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Common Name | Surgical Mask | Surgical Mask | Surgical Mask | Same |
| Device TradeName | FLUIDSHIELD* 1Procedure Mask with SOSOFT* Lining and SOSOFT* Earloops,Lavender (25868) | FLUIDSHIELD* 1 Fog-FreeProcedure Mask with SOSOFT* Lining and SOSOFT* Earloops,Lavender, Wrap AroundVisor (41798) | KC100 ProcedureMask | Different |
| Indications forUse | The FLUIDSHIELD* 1Procedure Mask(s) areintended to be worn toprotect both the patientand healthcarepersonnel from transferof microorganisms, bodyfluids, and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure of thewearer to blood andbody fluids.FLUIDSHIELD* 1Procedure Mask(s) aresingle use, disposabledevice(s), provided non-sterile. | The FLUIDSHIELD* 1Procedure Mask(s) areintended to be worn toprotect both the patientand healthcare personnelfrom transfer ofmicroorganisms, bodyfluids, and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure of thewearer to blood andbody fluids.FLUIDSHIELD* 1Procedure Mask(s) aresingle use, disposabledevice(s), provided non-sterile. | The Kimberly-ClarkKC100 Face Mask(s)is intended to beworn to protectboth the patientand healthcarepersonnel fromtransfer ofmicroorganisms,body fluids, andparticulatematerial. These facemasks are intendedfor use in infectioncontrol practices toreduce thepotential exposureof the wearer toblood and bodyfluids. TheKimberly-ClarkKC100 face mask(s)is a single use,disposabledevice(s), provided | SameThe devicetradenames aredifferent |
| non-sterile. | ||||
| Over-the-Counter / | ОТС | ОТС | ОТС | Same |
| Prescription | ||||
| Design Attributes | ||||
| Number ofLayers | 3 | 3 | 3 | Same |
| Color | Lavender | Lavender | Yellow, blue, green,white, lavender | Same |
| Style | Pleated with earloops | Pleated with earloops | Pleated with earloops | Same |
| Outer Layer | Spunbond polypropylene | Spunbondpolypropylene | Spunbondpolypropylene | Same |
| Middle Layer | Meltblownpolypropylene | Meltblownpolypropylene | Meltblownpolypropylene | Same |
| Inner Layer | Polyethylene/polyester | Polyethylene / polyester | Polyethylene /polyester | Same |
| Bindings | Polyester spunlace /polyester spunbond | Polyester spunlace /polyester spunbond | Polyester spunlace /polyester spunbond | Same |
| Earloop | Polyester/lycra | Polyester / lycra | Polyester / lycra | Same |
| Nose wire | Polyethylene coated steelwire / malleablealuminum | Polyethylene coatedsteel wire / malleablealuminum | Aluminum orpolyethylene coatedsteel | Same |
| Visor | None | Polyester film | Includes models withpolyester film visorand models without avisor | Same |
| Nose Foam | None | Blue polyester foam | Includes models withblue polyester nosefoam and modelswithout nose foam | Same |
| MaskDimensionLength | 6.875" ± 0.125" | 6.875" ± 0.125" | 6.875" ± 0.125" | Same |
| MaskDimensionWidth (Flat) | 3.625" +/-0.125" | 3.625" +/-0.125" | 3.625" +/- 0.125" | Same |
| Performance Data/Product Claims | ||||
| ASTM F2100Level | 1 | 1 | 1 | Same |
| EN 14683 | Type II | No | No | Different |
| Single Use | Yes | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| FluidResistanceASTM F1862 | 80 mmHg | 80 mmHg | 80 mmHg | Same |
| ParticulateFiltrationEfficiencyASTM F2299 | ≥ 95% | ≥ 95% | ≥ 95% | Same |
| Differentialpressure | < 5.0 mmH2O/cm² | < 5.0 mmH2O/cm² | < 5 mmH2O/cm² | Same |
| BacterialFiltrationEfficiencyASTM F2101 | ≥ 95% | ≥ 95% | ≥ 95% | Same |
| Flame Resistance16 CFR 1610 | Class 1 | Class 1 | Class 1 | Same |
| ISO 10993-5 | Under the conditions ofthe testing, not cytotoxic | Under the conditions ofthe testing, not cytotoxic | Under the conditions ofthe testing, not cytotoxic | Same |
| ISO 10993-10 | Under the conditions ofthe testing, not asensitizer and not anirritant | Under the conditions ofthe testing, not asensitizer and not anirritant | Under the conditions ofthe testing, not asensitizer and not anirritant | Same |
O&M Halyard, Inc.
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Image /page/6/Picture/0 description: The image shows the logo for Owens & Minor. The left side of the logo is a maroon-colored emblem with horizontal lines. The right side of the logo has the company name, "Owens & Minor", in gray text. The ampersand symbol is between the two words.
O&M Halyard, Inc.
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Image /page/7/Picture/0 description: The image shows the logo for Owens & Minor. The left side of the logo is a maroon-colored graphic with horizontal lines. To the right of the graphic is the text "Owens & Minor" in gray.
Summary of Non-Clinical Testing:
| Test | Purpose | Criteria | Result |
|---|---|---|---|
| ASTM F2101 | To demonstrate adequatebacterial filtration efficiency | Under the conditions of the study,at least 95% efficiency | Pass |
| EN 14683:2019+AC Annex C | To demonstrate acceptablebreathability | Under the conditions of the study,at most 5.0 mm H2O/cm² | Pass |
| ASTM F2299 | To demonstrate adequateparticulate filtration efficiency | Under the conditions of the study,at least 95% efficiency | Pass |
| ASTM F1862 | To demonstrate adequateresistance to liquids | Under the conditions of the study,passing at 80 mmHg conditions | Pass |
| 16 CFR 1610 | To evaluate flame spreadresistance | Class 1 under the conditions ofthe testing | Pass |
| ASTM F2100-19 | To evaluate mask performance | Level 1 under the conditions of theevaluation | Pass |
| EN ISO 11737-1 Bioburden | To evaluate microbial cleanliness | Under the conditions of the study,at most 30 CFU/g | Pass |
| ISO 10993-5 | To evaluate the cytotoxicpotential of the mask | Under the conditions of the study,non-cytotoxic | Pass |
| ISO 10993-10 Sensitization | To evaluate the sensitizationpotential of the mask | Under the conditions of the study,not a sensitizer | Pass |
| ISO 10993-10 Irritation | To evaluate the irritation potentialof the mask | Under the conditions of the study,not an irritant | Pass |
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Image /page/8/Picture/0 description: The image shows the logo for Owens & Minor. The left side of the logo is a maroon-colored symbol that appears to be the letters "OM" with horizontal lines running through them. To the right of the symbol is the text "Owens & Minor" in a gray sans-serif font. The ampersand symbol is also in gray and is positioned between the two words.
Summary of Clinical Testing
No clinical testing was performed in support of this submission.
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868), FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) are as safe, as effective and perform as well as or better than the legally marketed predicate device KC100 Face Masks (K110455).
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.